TelemedicineNCT01821014
Satellite-supplementation of Medical Outreach Clinics: a Feasibility Study
A study testing Telemedicine and In-person physician interaction in people with Telemedicine and Primary Health Care, run by Mayo Clinic at 1 site in Honduras.
Trial summary
Much of the basic general medical care and chronic disease management in rural Honduras comes from groups of volunteers setting up temporary clinics run by volunteers. These clinics, also known as brigades, or medical missions, are often criticized for their lack of quality and the lack of follow-up, both of which… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Telemedicine, Primary Health Care, Developing Countries
- What is being tested?
- Telemedicine and In-person physician interaction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteHonduras
- Study dates
- Feb 2013to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to give informed consent
- Non-emergent medical complaints
- At least 18 yrs in age
Who cannot join
- Pregnancy
- Mental Disability
Trial locations and contacts
1 site in 1 country.
About this study
Much of the basic general medical care and chronic disease management in rural Honduras comes from groups of volunteers setting up temporary clinics run by volunteers. These clinics, also known as brigades, or medical missions, are often criticized for their lack of quality and the lack of follow-up, both of which stem, in part, from understaffing with volunteer physicians. This study is designed to assess if it is feasible, safe, and acceptable to treat patients in short-term mobile medical clinics in rural Honduras using US physicians connected with patients by videoconference.
- Conditions
- Telemedicine, Primary Health Care, Developing Countries, Diagnosis, Therapeutics
- Being tested
- Telemedicine, In-person physician interaction
- Keywords
- Diagnostic concordance, Treatment concordance, patient satisfaction, physician satisfaction, Medical Outreach Clinics, Medical Brigades, Medical Missions, Telemedicine, Videoconference, diagnoses, treatments, Satellite Internet, VSAT, cross cultural telemedicine
- Medical subject headings
- Disease, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
Also called Videoconference, Skype
Patients undergo a detailed history and examination to the degree that is possible using the videoconference program, skype, a digital camera for high-resolution images, and an electronic stethoscope. A clinic volunteer aids with examination, translation and documentation.
In-person physician interactionOther
Also called in-person visit, in-person examination, in-person consultation
Patients undergo a detailed history and examination by an in-person physician. A clinic volunteer aids with examination, translation and documentation, as needed.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine First | Experimental | Patients whose first physician visit during the clinic was using videoconference, a form of telemedicine, and whose second physician visit during the clinic was with a physician in-person. Receives: Other: Telemedicine; Other: In-person physician interaction |
| Telemedicine Second | Experimental | Patients whose first physician visit during the clinic was with a physician in-person, and whose second physician visit during the clinic was using videoconference, a form of telemedicine. This is the reverse order of visits of the "Telemedicine fist" arm. Receives: Other: Telemedicine; Other: In-person physician interaction |
| Two physician visits | Active comparator | Patients who had two sequential visits with different in-person physicians. Receives: Other: In-person physician interaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Diagnoses
The diagnoses resulting from the two physician visits will be compared and a cohen's kappa statistic will be calculated for diagnoses between the visits.
Measured: Same Day as clinic visit (less than 6 hours)
Recommended clinical treatments
After each of a patient's two physician visits, the physician's resulting recommended treatments will be gathered for comparison between the two visits.
Measured: Same Day as clinic visit (less than 6 hours)
Secondary outcomes (3)
Patient opinions of physician interactions
Patients will receive a survey following each interaction with a doctor. These surveys cover communication, comfort and satisfaction.
Measured: Immediately following physician interactions (less than 6 hours)
Physician opinions of patient interactions
doctors will fill out a survey about their patient interactions after they complete their experience volunteering with the clinic.
Measured: immediately following volunteer activities with the clinic (less than 48 hours)
Volunteer opinions of physician-patient interactions
Volunteers who helped with physician interactions will receive a survey about their experience concerning physician patient communication, volunteer educational value and perceived value of the experience.
Measured: immediately following experience with the clinic (Less than 48 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bart M. Demaerschalk, Mayo Clinic
- Investigators
- Bart Demaerschalk, MD/MSc, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821014
- Sponsor's protocol ID
- 13-000132
- Status last verified
- May 2014
- First submitted
- 20 Mar 2013
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satellite-supplementation of Medical Outreach Clinics: a Feasibility Study
- ClinicalTrials.gov ID
- NCT01821014
- Acronym / sponsor ID
- 13-000132
- Conditions
- Telemedicine, Primary Health Care, Developing Countries, Diagnosis, Therapeutics
- Keywords
- Diagnostic concordance, Treatment concordance, patient satisfaction, physician satisfaction, Medical Outreach Clinics, Medical Brigades, Medical Missions, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 29 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Much of the basic general medical care and chronic disease management in rural Honduras comes from groups of volunteers setting up temporary clinics run by volunteers. These clinics, also known as brigades, or medical missions, are often criticized for their lack of quality and the lack of follow-up, both of which stem, in part, from understaffing with volunteer physicians. This study is designed to assess if it is feasible, safe, and acceptable to treat patients in short-term mobile medical clinics in rural Honduras using US physicians connected with patients by videoconference.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Telemedicine First | Experimental | Other: Telemedicine, Other: In-person physician interactionPatients whose first physician visit during the clinic was using videoconference, a form of telemedicine, and whose second physician visit during the clinic was with a physician in-person. |
| Telemedicine Second | Experimental | Other: Telemedicine, Other: In-person physician interactionPatients whose first physician visit during the clinic was with a physician in-person, and whose second physician visit during the clinic was using videoconference, a form of telemedicine. This is the reverse order of visits of the "Telemedicine fist" arm. |
| Two physician visits | Active comparator | Other: In-person physician interactionPatients who had two sequential visits with different in-person physicians. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to give informed consent
- Non-emergent medical complaints
- At least 18 yrs in age
Key exclusion criteria (2 listed)
- Pregnancy
- Mental Disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemedicineAlso: Videoconference, SkypePatients undergo a detailed history and examination to the degree that is possible using the videoconference program, skype, a digital camera for high-resolution images, and an electronic stethoscope. A clinic volunteer aids with examination, translation and documentation. | Other | Telemedicine First, Telemedicine Second |
| In-person physician interactionAlso: in-person visit, in-person examination, in-person consultationPatients undergo a detailed history and examination by an in-person physician. A clinic volunteer aids with examination, translation and documentation, as needed. | Other | Telemedicine First, Telemedicine Second, Two physician visits |
Primary outcome
Clinical Diagnoses
Time frame: Same Day as clinic visit (less than 6 hours)
The diagnoses resulting from the two physician visits will be compared and a cohen's kappa statistic will be calculated for diagnoses between the visits.
Recommended clinical treatments
Time frame: Same Day as clinic visit (less than 6 hours)
After each of a patient's two physician visits, the physician's resulting recommended treatments will be gathered for comparison between the two visits.
3 secondary outcomes
Patient opinions of physician interactions
Time frame: Immediately following physician interactions (less than 6 hours)
Physician opinions of patient interactions
Time frame: immediately following volunteer activities with the clinic (less than 48 hours)
Volunteer opinions of physician-patient interactions
Time frame: immediately following experience with the clinic (Less than 48 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart Demaerschalk, MD/MSc principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine and In-person physician interaction in people with Telemedicine and Primary Health Care, run by Mayo Clinic at 1 site in Honduras.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Honduras. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Diagnoses (time frame: Same Day as clinic visit (less than 6 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2014.